This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.

Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen

CD4 cell counts were measured using standard of care testing via local laboratories.

Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.

EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.

Eligibility

Ages Eligible for Study:

16 Years and older (Child, Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

The study population consists of individuals who were previously enrolled in raltegravir expanded access program(EAP) and completed at least 8 weeks of treatment with raltegravir, whose chart from EAP program is available for review, and whose resistance testing prior to initiation of raltegravir is available.

Criteria

Inclusion Criteria:

Patients previously enrolled in the MK 0518 EAP are eligible

Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:

Age >= 16 years

Limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral ARTs (NRTI, NNRTI, PI) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. Patient did not achieve virologic suppression on ART regimen prior to receipt of raltegravir iv. Patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except ARTs) unchanged for >= 2 weeks prior to raltegravir receipt.

Patient received raltegravir for at least 8 weeks

Baseline and week 8 or later HIV viral load done and available for review

Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir

Exclusion Criteria:

Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.

Patient chart not available for review.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751530

Locations

United States, California

Light Source Medical

Los Angeles, California, United States, 900036

AIDS Healthcare Foundation

Los Angeles, California, United States, 90028

Synergy Hematology and Oncology

Los Angeles, California, United States, 90036

Quest Clinical Research

San Francisco, California, United States, 94115

United States, Connecticut

Connecticut Health Care Group

Glastonbury, Connecticut, United States, 06033

United States, District of Columbia

Dupont Circle Physicians Group

Washington, District of Columbia, United States, 20009

Capital Medical Associates PC

Washington, District of Columbia, United States, 20036

United States, Florida

Orlando Immunology Center

Orlando, Florida, United States, 32803

United States, Illinois

Ruth M. Rothstein CORE Center

Chicago, Illinois, United States, 60612

United States, Massachusetts

Community Research Initiative

Boston, Massachusetts, United States, 02215

Community Research Initiative - West

Springfield, Massachusetts, United States, 01107

United States, New York

Infectious Diseases and HIV Medicine Immunodeficiency Clinic

Buffalo, New York, United States, 14215

Bellman, MD

New York, New York, United States, 10003

United States, Pennsylvania

Mounzer, MD

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Dr. Nicholaos C. Bellos & Associates

Dallas, Texas, United States, 75204

Sponsors and Collaborators

Community Research Initiative of New England

Investigators

Principal Investigator:

Daniel Skiest, MD

Community Research Initiative

More Information

Responsible Party:

Daniel Skiest, MD, Principal Investigator, Community Research Initiative of New England